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FDA Approves New Melanoma Treatment

Posted: March 28, 2011

The U.S. Food and Drug Administration (FDA) has approved Bristol-Myers' Yervoy for the treatment of late-stage, metastatic melanoma, a deadly skin cancer.

Yervoy (ipilimumab) is the first drug ever shown to help late-stage melanoma patients live longer. However, it does not cure the disease.

"Late-stage melanoma is devastating, with very few treatment options for patients, none of which previously prolonged a patient's life," Richard Pazdur, MD, director of the FDA's cancer drugs office, says in a news release.

In a clinical trial with 676 late-stage melanoma patients for whom all other treatments had failed -- and for whom surgery was not an option -- patients taking Yervoy survived an average of 10 months after starting treatment. Patients taking an experimental vaccine lived an average of 6.5 months.

Yervoy also appears to extend survival when used as a first-line treatment for inoperable stage III or stage IV melanoma, Bristol-Myers announced earlier this week. Details of the study will be reported at the June meeting of the American Society of Clinical Oncology.